Intraocular lens storage and loading devices and methods of use

ABSTRACT

Intraocular lens loading devices and methods of use. In some embodiment the devices are used to sequentially splay first and second haptics while loading the intraocular lens into a delivery lumen.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/357,463 filed Jun. 24, 2021, which is a continuation of U.S. patentapplication Ser. No. 16/268,280 filed Feb. 5, 2019, now U.S. Pat. No.11,071,622, which is a continuation of U.S. patent application Ser. No.14/776,752 filed Sep. 15, 2015, now U.S. Pat. No. 10,195,020, which is a371 application of PCT/US2014/030353 filed Mar. 17, 2014, which claimsthe benefit of U.S. Prov. Patent App. No. 61/799,755 filed Mar. 15,2013, the disclosure of each is incorporated by reference herein.

This application is related to and incorporates by reference herein thedisclosure of U.S. Pub. No. US 2014/0012277, published Jan. 9, 2014.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND

Procedures for loading and/or splaying haptics of an intraocular lens(“IOL”) that use many individual tools or components, and involvemanually displacing an IOL from an IOL carrier or other storage deviceinto a delivery device or delivery lumen can be cumbersome and can riskdamaging the IOL and delivery performance. An assembly that allows theuser to quickly, reliably, and safely introduce an IOL into a deliverydevice or delivery lumen without manual manipulation or at least withoutrisk of IOL damage would provide advantages over existing approaches.

SUMMARY OF THE DISCLOSURE

One aspect of the disclosure is a method of reconfiguring an intraocularlens haptic for delivery, comprising providing an intraocular lens in anintraocular lens receiving region of a base member such that a leadinghaptic is in a substantially at-rest configuration relative to an opticportion of the intraocular lens; moving a free end of the leading hapticaway from the optic portion and towards a delivery lumen with anactuatable splaying member.

In some embodiments the substantially at-rest configuration is a curvedconfiguration. The curved configuration can closely follow the curvatureof an intraocular lens optic portion periphery.

In some embodiments the providing step comprises a trailing haptic in asubstantially at-rest configuration relative to the optic portion of theintraocular lens.

In some embodiments the providing step comprises at least a portion ofthe leading haptic being positioned distally relative to a distal mostportion of the optic portion.

In some embodiments moving the free end comprises moving the free endtowards the delivery lumen without substantially moving a free end of atrailing haptic away from the optic portion.

In some embodiments moving the free end comprises moving the free endwith an axially directed force from the splaying member.

In some embodiments moving the free end comprises engaging the free endwith the actuatable splaying member.

In some embodiments moving the free end comprises distally moving thesplaying member relative to the base member.

In some embodiments moving the free end comprises moving the free endfrom a position directly adjacent the optic periphery to a positionfurther away from the optic periphery.

In some embodiments the providing step comprises the free end beingcloser to a first side of a base member channel than a second side of abase member channel, and the free end being accessible for directengagement in the proximal direction.

In some embodiments moving the free end creates a bend in the leadinghaptic wherein a free end portion of the leading haptic extends awayfrom an attached end portion of the leading haptic. Moving the free endcan create a bend at a location in the leading haptic that ispredisposed to bending when the free end is actuated with the splayingmember.

In some embodiments the method further comprises moving a free end of atrailing haptic away from the optic portion. Moving the free end of thetrailing haptic can comprise moving the free end of the trailing hapticin a proximal direction away from the leading haptic free end. Movingthe free end of the trailing haptic can be moved upon a second actuationmember.

In some embodiments the method further comprises loading the intraocularlens into the delivery lumen. The delivery lumen can be part of aseparate delivery device. The delivery lumen can be integral with thebase member. The delivery lumen can be part of the base member.

One aspect of the disclosure is a method of splaying leading andtrailing haptics of an intraocular lens in preparation for delivery intoan eye, comprising splaying a leading haptic relative to an opticportion of an intraocular lens with an actuatable splaying member; andsplaying a trailing haptic relative to the optic portion, whereinsplaying the leading haptic is initiated prior to initiating thesplaying of the second haptic.

In some embodiments splaying the leading haptic is completed prior toinitiating the splaying of the second haptic.

In some embodiments the method further comprises loading the intraocularlens into a delivery lumen.

In some embodiments splaying the trailing haptic occurs as a result ofadvancing the optic portion distally with an actuatable loading member,and wherein the actuatable loading member does not directly the free endof the trailing haptic.

One aspect of the disclosure is a method of splaying leading andtrailing haptics of an intraocular lens in preparation for delivery intoan eye, comprising actively splaying a leading haptic and passivelysplaying a trailing haptic. Actively splaying can comprise splaying theleading haptic free end by engaging and moving the leading haptic freeend with an actuatable splaying member, and wherein passively splayingthe trailing haptic occurs as a result of forces on the trailing hapticfree end from a non-actuatable component. Actively splaying can comprisesplaying the leading haptic free end by engaging and moving the leadinghaptic free end with an actuatable member, and wherein passivelysplaying the trailing haptic occurs as a result of a second actuatablemember applying forces to a portion of the intraocular lens other thanthe free end of the trailing haptic.

One aspect of the disclosure is a method of positioning an intraocularlens in a base carrier, comprising: positioning an intraocular lens inan intraocular lens receiving area in a base member such that a leadinghaptic free end is closer to one side of a base member channel and isaccessible for direct actuation in the proximal direction. The hapticfree end can be facing proximally.

One aspect of the disclosure is a device for reconfiguring anintraocular lens in preparation for delivering the intraocular lens intoan eye, comprising a base member comprising an intraocular lensreceiving portion; a splaying member adapted to interact with the basemember to engage and splay a leading haptic of an intraocular lenspositioned in the lens receiving area; and a loading member adapted tointeract with the base member to engage the intraocular lens after theleading haptic has been splayed and to advance the intraocular lenstowards a delivery lumen.

In some embodiments the splaying member is configured to be axiallymovable relative to base member.

In some embodiments the splaying member interacts with the base membersuch that a distal end is not aligned with the center of the intraocularlens receiving area.

In some embodiments the splaying member interacts with the base membersuch that a distal end of the splaying member is disposed on a side ofthe lens receiving area.

In some embodiments the splaying member has branched distal end.

In some embodiments the base member has an element configured to matewith the branched distal end to prevent further distal movement.

In some embodiments the splaying member engages a first side wall of abase member channel and is slidable thereon.

In some embodiments the loading member is adapted to be axially movablerelative to the base member.

In some embodiments the splaying member and the loading member areradially offset from one another in the base member. The base member cancomprise a dividing element that maintains the relative positions of thesplaying member and the loading member.

In some embodiments the loading member comprises a first extensionextending distally from a top of a loading member body, and a secondextension extending distally from the loading member body below thefirst extension, the first extension having a length greater than alength of the second extension.

In some embodiments the first extension extends distally and upwardlyfrom the loading member body.

In some embodiments the first extension is adapted to flex where itextends upwardly from the loading member body. The loading member caninteract with the base member such that as the loading member isadvanced distally the first extension is disposed over a central regionof the lens receiving area. The device can further comprise a lidadapted to be secured to the base member over the intraocular lensreceiving area, the lid comprising a guide element adapted to engagewith and cause the lowering of the first extension as the loading memberis advanced distally.

In some embodiments the base member comprises a loading member lock outthat prevents the loading member from being distally advanced until thelock out is moved, and wherein the splaying member comprises a releaseto move the lock out.

In some embodiments the base member comprises a trailing hapticreceiving portion extending generally radially relative to the basemember channel.

In some embodiments the device further comprises a lid comprising aplurality of posts configured to be disposed in a plurality ofcorresponding post guides in the base member. The lid can comprise aplurality of compression spokes extending downward from a bottom surfaceof the lid, the spokes adapted to engage with a leading haptic and atrailing haptic of the intraocular lens to lightly compress the haptics.In some embodiments at least two spokes engage each of the haptics.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-13 illustrate an intraocular lens loading process using anexemplary carrier in which leading and trailing haptics are splayed andthe intraocular lens is loaded into a delivery lumen. The haptics aresplayed in the delivery lumen.

FIG. 14 illustrates an exemplary intraocular lens carrier and loadingdevice.

FIG. 15 illustrates an exemplary viscoelastic port adjacent to and influid communication with an intraocular lens receiving area in acarrier.

FIG. 16 illustrates an exemplary intraocular lens carrier and loadingdevice.

FIG. 17 is an exploded view of the intraocular lens carrier and loadingdevice from FIG. 16 .

FIG. 18 is an exploded view showing an exemplary cartridge that can besecured to the exemplary carrier and loading device.

FIG. 19 shows the cartridge secured to the loading device.

FIG. 20 shows an exemplary distal end of an exemplary loading member.

FIG. 21 shows a bottom surface of an exemplary lid.

FIG. 22 illustrates an exemplary intraocular lens receiving area of acarrier, with an intraocular lens therein.

FIGS. 23A and 23B illustrate an exemplary carrier with bottom and topplugs.

FIG. 24 is a top view with a top plug removed, with an optic portionvisible through the window.

FIGS. 25A and 25B show top and bottom perspective exploded views of anexemplary lid with removable plug.

FIGS. 26A and 26B show top and bottom perspective views of an exemplarylid with removable plug secured thereto.

FIG. 27A shows a top exploded view of an exemplary carrier and bottomplug that incorporates a viscoelastic port.

FIG. 27B shows a bottom exploded close up view of an exemplary carrierand bottom plug that incorporates a viscoelastic port.

FIG. 28 illustrates an exemplary bottom plug that incorporates aviscoelastic port.

FIG. 29 is a top perspective assembled view showing a bottom plugsecured to a carrier, showing fluid communication between a viscoelasticport and an intraocular lens receiving area.

FIG. 30 is a bottom view showing an exemplary bottom plus withviscoelastic port secured to a bottom of a carrier with a plurality oflocks.

FIGS. 31A and 31B are top and bottom assembled views showing top andbottom plugs secured to a carrier, with the bottom plug having aviscoelastic port.

FIGS. 31C and 31D are close up views from FIGS. 31A and 31B.

FIGS. 32A-C illustrate an exemplary sequence of splaying leading andtrailing haptics while loading an intraocular lens into a deliverylumen.

DETAILED DESCRIPTION

Some aspects of this disclosure describe storage devices for anintraocular lens. Some aspects of the disclosure describe devices andassemblies for loading an intraocular lens into a delivery device ordelivery lumen. In some embodiments the devices and assemblies can beused for both storage and loading.

FIGS. 1-13 illustrate an exemplary embodiment of an IOL loading device,including a sequence of loading an exemplary intraocular lens into adelivery device. While FIGS. 1-13 are descried in the context ofintraocular lens loading, the devices and assemblies in FIGS. 1-13 couldalso be used to store the intraocular lens. “Storage” as used hereinincludes any time the intraocular lens is kept in the device, andincludes any sterilization procedures, shipping, and/or storage.

The loading devices herein are adapted to splay at least one haptic ofthe intraocular lens. The embodiment shown in FIGS. 1-13 illustrates adevice adapted to splay two haptics of an intraocular lens, and isadapted to splay the two haptics sequentially. The term “splay” (orderivatives of “splay”) as used herein refers to the act of re-orientingat least a portion of a haptic relative to an optic portion of anintraocular lens, such as from a substantial at-rest orientation inwhich the haptic has a generally curvilinear configuration to anorientation in which the haptic extends away from the optic. In thesplayed orientation, at least a portion of the haptic does not followthe periphery of the optic portion, and extends away from the opticportion. In the splayed orientation a free end of the haptic is disposedfurther from the periphery of the optic than when the haptic is at anat-rest orientation relative to the optic. In the splayed orientation,at least a portion of the haptic has a more linear configuration thanwhen the haptic is in the at-rest configuration.

The device(s) in FIGS. 1-13 are adapted to be used to load an IOL, suchas the exemplary accommodating intraocular lens shown, into a deliverydevice or delivery lumen, from which the IOL is delivered into apatient's eye (such as into a capsular bag after the native capsule hasbeen removed). A “delivery device” or “delivery lumen” as used hereinmay be referred to as a cartridge, and generally refers to a device orlumen that houses at least a portion of the intraocular lens for anyperiod of time before the intraocular lens is implanted into the eye.

As an example, the loading devices and methods herein can be used toload an IOL into the cartridges described in U.S. application Ser. No.13/835,876, filed Mar. 15, 2013, the disclosure of which is incorporatedby reference herein. They can also be used to load an IOL into anysuitable type of delivery device or delivery lumen.

The IOLs that can be loaded and splayed using devices and methods hereincan be any type of IOL, such as accommodating, monofocal, and multifocalIOLs. FIGS. 1-13 illustrate the exemplary splaying of first and secondhaptics and the loading of a fluid-filled and fluid-driven accommodatingIOL, exemplary details of which are described in U.S. application. Ser.No. 13/672,608, filed Nov. 8, 2012, while exemplary methods ofdelivering the IOL from the delivery device and into the eye aredescribed in U.S. application Ser. No. 13/835,876, filed Mar. 15, 2013.

Procedures for loading and/or splaying of haptics that use manyindividual tools or components, and involve manually displacing an IOLfrom an IOL carrier or other storage device into a delivery device(e.g., cartridge) can be cumbersome and can risk damaging the lens anddelivery performance. Preferable options include an assembly that allowsthe user to quickly, reliably, and safely introduce an IOL into adelivery device (e.g., a cartridge) without manual manipulation or atleast without risk of IOL damage.

FIGS. 1-13 illustrate an exemplary splaying and loading lens carrierassembly that allows for safe transport of an accommodating IOL frommanufacturing, through sterilization, storage, and into the operatingenvironment. It does this with the lens in a substantially unstressedstate to not alter power or shape of the lens through sterilization orstorage. When ready for lens delivery, the loading IOL carrier can bemounted to a delivery device (e.g., a cartridge), which places the lensin a preferred state ready to deliver. The carriers herein are adaptedto mate with cartridge and tray assemblies described in U.S. applicationSer. No. 13/835,876, filed Mar. 15, 2013, such that the IOL can beloaded into those cartridges, but the disclosure is not so limited. Thecarrier assemblies herein can be used to load IOLs into other types ofdelivery devices.

As shown in the top view in FIG. 1 , exemplary carrier 10 includes base12, which acts as a tray to interface with other loading IOL carriercomponents as well as delivery system components (e.g., a cartridge).Base 12 also includes an IOL receiving region formed therein, and alsoacts as a guide for the IOL through the splay and loading process. Thecarrier assembly also includes a splay member 20. The splay member isadapted to move distally and proximally within a channel or guide inbase 12 and functions to splay leading haptic 4 in a direction distal tooptic 2 of IOL 3. The carrier assembly also includes loading memberguide 22, which houses a loading member that moves distally to engagewith and advance IOL 3 into cartridge 30 (or other delivery device ordelivery lumen) and placing it at a predefined position in the cartridgeto be ready for further assembly of a delivery device, such as theplungers described in U.S. application Ser. No. 13/835,876, filed Mar.15, 2013. The carrier assembly also includes a carrier cover, or lid,not shown in FIGS. 1-13 for clarity. The cover retains the IOL, splaymember, and loading member in the assembly. It also allows forviscoelastic lubricant to be introduced into the system withoutdisrupting the lens orientation. It also allows for visualization of theloading procedure.

FIG. 1 illustrates IOL 3 within an IOL receiving region in base 12.Leading haptic 4 is disposed distally to optic 2, and trailing haptic 6is generally proximal to optic 2. Splay member 20 is disposed withinchannel 15 in base 12. Splay member 20 has an extension on one side ofthe member 20 that, when the splay member 20 in advanced in channel 15,is adjacent a side wall of channel 15. In FIG. 1 the extension is shownon the bottom of splay member 20. The IOL is positioned within thereceiving region, and the extension is disposed within base 12, suchthat the extension is positioned to engage with the free end of leadinghaptic 4 and initiate the splaying process as splaying member 20 isadvanced distally.

FIG. 2 illustrates an exploded view with cartridge 30 separate fromcarrier base 12, but illustrating the end to which cartridge 30 isadapted to be secured to carrier base 12. FIG. 3 shows cartridge 30secured to base 12.

FIGS. 1-7 illustrate an exemplary method of splaying a leading haptic ofthe IOL within the carrier base. Prior to use, the loading IOL carriercan be sterilized and shipped with the IOL disposed therein (as shown inFIG. 1 ). Optionally the cartridge can be attached before sterilization,or the cartridge can be attached at the time of loading. Viscoelastic isintroduced to the carrier through a port in the side of the loading IOLcarrier that has a communicating port adjacent to lens, an example ofwhich is shown in FIG. 15 . Addition of viscoelastic lubricates the IOL,carrier, and cartridge components to allow for orientation and movementof the lens without sticking.

FIG. 1 illustrates the IOL within the carrier base such that the hapticsare in an at-rest configuration and orientation, and are substantiallyunstressed. In the at-rest orientation, the haptics are both generallycurvilinear, and extending around the periphery of optic 2. Trailinghaptic 6 is oriented generally towards trailing haptic guide 14, whichextends radially outward from channel 15. Both haptics closely followthe curvature of the optic portion, unlike some wire haptics, whichextend further away from the optic portion and do not closely follow thecurvature of the optic periphery. FIG. 3 illustrates the carrier mountedto cartridge 30. When the carrier is mounted to the cartridge, as shownin FIG. 3 , the carrier channel 15 is in communication with a deliverylumen within the cartridge that is adapted to receive the IOL.

As can be seen in FIG. 1 , splay member 20 includes an elongate distalportion extending from the proximal portion and is aligned with one sideof the channel so that the distal end is positioned (and adapted) toengage and push the leading haptic distally when the splay slide isadvanced. The IOL is oriented rotationally in FIG. 1 such that theelongate portion is adapted to push on the free end of the haptic (i.e.,not the end of the haptic that is directly attached to optic 2). Thefree end is facing proximally and is accessible in the proximaldirection.

FIGS. 4-7 are top views of base 12 illustrating an exemplary sequence ofsplaying a leading haptic of an IOL. An operator actuates splay member20 to advance it distally, causing splay member 20 to engage with thefree end of leading haptic 4, as shown in FIG. 5 . As splay member 20continues to be advanced distally, the extending portion of splay member20 pushes the free end of leading haptic 4 away from the periphery ofoptic 2, changing the configuration of the haptic and the haptic'sorientation relative to optic 2. Surgeon features in the haptic thatallow for fluid (e.g., viscoelastic fluid) to be advanced or aspiratedduring the procedure act as a natural hinge, and leading haptic 4 willnaturally bend at that location. The surgeon feature is described inmore detail in the applications reference herein, but in general thesurgeon feature is a region of decreased thickness relative to adjacentportions of the haptic that creates an opening between the optic and thehaptic radially inner surface. As splay member 20 continues to bedistally advanced, the distal end of leading haptic 4 continues tosplay, as shown in FIG. 6 , starting to extend generally in the distaldirection. Continued splay member 20 advanced continues until finger 24engages pocket 13 in the base, and further distal movement of splaymember 20 is prevented. Leading haptic 4 is splayed in FIG. 7 , with thefree end of the haptic extending in the distal direction, and the hapticreconfigured to a splayed configuration. The trailing haptic can undergoa relatively minimal amount of deformation as the leading haptic issplayed, but is not considered to be splayed as that term is usedherein. In FIG. 7 the trailing haptic is not yet splayed. In thisembodiment the leading haptic is “actively” splayed into that anactuatable member makes direct contact with the free end of the haptic.

After the leading haptic is splayed, the IOL is then loaded into thecartridge, during which the trailing haptic is also splayed. In thisembodiment the trailing haptic is passively splayed in that it issplayed as a result of a force being applied to a non-free end of thetrailing haptic. The carrier base need not be moved relative to thecartridge at this point. Splay member 20 is not advanced any further toload the IOL into the cartridge, in this embodiment due to the stop 11in the base.

FIGS. 8-13 illustrate an exemplary loading process that loads the IOLinto the cartridge after the leading haptic has been splayed. During theloading the trailing haptic is passively splayed. A loading member 40,which is optionally mechanically coupled to the splay member, isadvanced distally within a channel or guide in the splay member, asshown in FIG. 8 . Loading member 40 has an elongate distal portion sizedand configured for advancement within and relative to the splay memberchannel. The distal end of loading member 40 is adapted to push the IOLinto the cartridge (i.e., load the IOL into the cartridge). To load theIOL, the operator distally advances loading member 40, moving the IOLforward within carrier, as shown in FIGS. 9 and 10 . During the loadingprocess trailing haptic 6 is deformed against the channel wall as theIOL is advanced further down the carrier channel. In FIG. 10 trailinghaptic 6 is significantly splayed proximally relative optic, and bendsat the surgeon feature as described above in the context of the leadinghaptic. The free end portions of the haptics extend away from the opticportion, while the attachment portions of the haptics do not extend awayfrom the optic portion as much. In these embodiments the free endportions are considered the portions distal to the bend locations of thehaptics. As the IOL is about to be loaded into the cartridge, theleading haptic is distally splayed and the trailing haptic is proximallysplayed. With the IOL shown, free end portions of each haptic arereconfigured. Loading member 40 continues to be advanced until the IOLis advanced into the cartridge delivery lumen, as shown in FIG. 13 . Asthe IOL is loaded, the optic undergoes deformation due to a taperedsurface of the cartridge. The haptics undergo additional reorientationrelative to the optic as the IOL is advanced into the cartridge. Loadingmember 40 is sized so that the IOL is advanced to a predeterminedposition within the cartridge, to ensure it is advanced far enough butnot out of the cartridge. A very small portion of the IOL could extendfrom the distal port of the cartridge. The operator then retracts theloading member within the carrier. The operator then removes the carrierfrom the cartridge to allow the positioning of other delivery devices,such as the delivery devices described in U.S. application. Ser. No.13/835,876, filed Mar. 15, 2013. Optionally, an additional deliverymember could be advanced through the carrier to deliver the IOL out ofthe cartridge.

FIG. 14 illustrates an additional embodiment of a carrier in whichloading member 40 is disposed to the side of splay member 20 rather thanaxially moveable within it. Cartridge 30 is shown secured to the distalportion of the carrier base.

Embodiments below show a protective cartridge bay, or cartridgereceiving area, included in the loading carrier base to allow thecartridge to be in the shipped assembly. The viscoelastic port (see FIG.15 ) can be designed to mate to standard syringes and has a pathway thatleads to proximity of the lens. The splay member and loading member canalso be coupled to allow the operator to continue one motion to allowfor splaying and loading of the IOL in one generally continuous act.

One or more components of the carrier can be, for example, machinedwhite acetal copolymer, but can be any other suitable material. Inalternative embodiments, a handheld loading tool can be used in place ofthe integrated loading slide, and is an example of using additionalcomponents with the carrier base and splay slide.

FIGS. 16-32C illustrate exemplary embodiments of intraocular lenscarriers that are adapted to store intraocular lenses, as well as toload intraocular lenses into a delivery device or delivery lumen. Thisdisclosure generally refers to a delivery device (e.g., a cartridge) asa device that is different than the carrier, but the delivery device andcarrier can be considered the same device in alternative embodiments. Inthose embodiments the intraocular lens can be loaded into a deliverylumen of the carrier. The carriers can be used to load an intraocularlens in either way. In the embodiment in FIGS. 16-32C they are separatecomponents adapted to mate with one another. The carriers in FIGS.16-32C are adapted to carry the exemplary accommodating intraocular lensin a stable, lightly axially-compressed condition (referred to herein asa “compressed condition”). The intraocular lens can be carried in thecompressed condition through, for example, sterilization, shipping, andstorage. The carriers in FIGS. 16-32C are also adapted for touch-freeloading of intraocular lenses into a delivery device for delivery in aneye.

FIG. 16 is a top view of an exemplary intraocular lens carrier. Carrier300 includes base 310, splay member 320, load member 330, and lid 350.Lid 350 is shown as transparent to allow intraocular lens 340 to be seenbetween lid 350 and base 310. FIG. 17 shows an exploded view with base310, load member 330, splay member 320, lens 340, and lid 350. Base 310has a channel or guide 311 (see FIG. 17 ) in the proximal portionadapted to receive the proximal portions of load member 330 and splaymember 320 therein. As shown in FIG. 16 , splay member 320 and loadmember 330 include elongate portions that are positioned generally nextto one another and extending in the proximal to distal direction(axially), while base 310 includes divider 312 that separates splaymember 320 from load member 330. Splay member 320, load member 330, andchannel 311 are all configured to allow splay member 320 and load member330 to be moved distally within channel as part of the splay and loadingprocess below. Base 310 also includes load member lock out 313 thatprevents load member 330 from being advanced distally until release 323of the splay member (see FIG. 17 ) engages and displaces lock out 313radially, thus allowing load member 330 to then be advanced distally.This prevents distal movement of load member 330 until splay member 320has been advanced far enough distally to ensure that the leading hapticis sufficiently splayed. Splay member 320 and load member 330 aresomewhat similar in function to the other splaying members and pushingmembers set forth above in FIGS. 1-13 . Base 310 also includes anintraocular lens receiving region 314 (see FIG. 17 ) that includestrailing haptic receiving area 315.

Splay member 320 in this embodiment has a distal portion 321 with ageneral forked, or branched, configuration. As shown in FIG. 17 , distalportion 321 includes first extension 322 and second extension 324 of thebranched configuration, with both extensions including first and secondflat surfaces. The angle between the two branches of the branchedconfiguration can be between about 60 degrees and about 120 degrees. Ifthe angle is too large distal portion 321 may not index to the landingposition after splaying. If the angle is too small distal end 321 maynot be able to pick up the leading haptic at the beginning of the splayprocess. In the embodiment shown the angle is 90 degrees. In someembodiments the angle is between about 75 degrees and about 105 degrees.The branched configuration of distal portion 321 is configured to matewith splay member stop 316 (see FIG. 16 ) in base 310. Second extension324 includes two flat surfaces, the flat surfaces defining an internalangle less than 90 degrees (such as 75 degrees or less, 60 degrees orless, or 50 degrees or less, such as about 45 degrees). The tip ofsecond extension 324 is configured to, when splay member 320 is advanceddistally, fit just between the free end of the leading haptic and theoptic portion of lens 340. The positioning of extension 324 in thismanner causes the leading haptic to start to splay when splay member isadvanced, which is described in more detail below.

FIG. 18 shows a perspective view of carrier 300 and cartridge 360 beforethe cartridge is secured to the distal cartridge receiving area ofcarrier 300. FIG. 19 shows the assembly after cartridge 360 is securedto the distal portion of carrier 300. In use, as will be describedbelow, the intraocular lens is loaded from its receiving region incarrier 300 into a delivery lumen in cartridge 360.

FIG. 20 illustrates distal end 331 of load member 330. Load member 330includes an elongate body 333, a first extension 332 extending distallyand in an upward direction relative to a top portion of elongate body333 at a hinge 335. First extension 332 is adapted to rotate withrespect to the portion of load body 333 proximal to extension 332 athinge 335. Load body 333 also includes second extension 334 extendingdistally and in a generally linear orientation with respect to theproximal portions of load body 333.

FIG. 21 shows a view of bottom surface 352 of lid 350. Lid 350 ispositioned on top of a portion of base 310, as shown in the explodedview in FIG. 24 . Lid 350 covers the portion of base 310 where the lens340 is positioned. Lid 350 includes a plurality of posts 353, which areadapted to fit within post guides 317 in base 310 (see FIG. 17 ) to helpstabilize lid 350 with respect to base 310. In this embodiment there arethree posts, although more or less can be used. It may be beneficial touse three posts, which develop a simple plane, whereas more posts mayincrease the risk of over constraint which could lead to increasedvariation in lens compression. Lid 350 also includes sight or probeapertures 354, which are described below. Lid 350 also includes aplurality of compression spokes 355 that extend downward (i.e., in thesame direction as posts 353) from the bottom surface 352 of the lid. Inthis embodiment there are four compression spokes 355, and they havelinear configurations extending radially away from the center of thelens receiving region.

Base 310 and lid 350 are adapted and configured to provide advantageswhen storing intraocular lens 340 for periods of time. Some types ofaccommodating intraocular lenses may be susceptible to undergoing powerchanges during storage due to, for example, degradation of IOL materialsor forces on the lens from the packaging components. Eliminating orgreatly reducing power changes during storage, or at least making thempredictable, is highly desirable. For example, lens 340 can be afluid-driven accommodating intraocular lens such as those incorporatedby reference herein. For example, the two haptics may include fluidchambers in fluid communication with the option portion. If the hapticsare compressed too greatly over time, fluid may transfer between thehaptics and optics, causing power changes to the IOL. The compressionspokes 355 of lid 350 provides a sufficient amount of compression tohaptics to stabilize them without distorting them. The spokes alsoisolate interaction between the haptics and the carrier to the spokes,which prevents haptic compression coming from a larger surface such asthe lid bottom surface. That is, the haptics are maintained in desiredconfigurations so that the IOL power change is predictable duringstorage. The manner of controlling the degree of haptic compression inthis embodiment uses an assembly method with finely controlled postheight coupled with an equally controlled height of the lens compressionfeature, in this embodiment the spokes. The bottoming of the posts inthe mating part of carrier base 310 controls a well-defined compressionbetween a base surface on which the lens rests and the lens compressionspoke. This compression holds the lens in a stabilized position throughstorage, which can include sterilization and shipping.

In this embodiment the posts are designed to sit on the plane of thebase on which the haptics are disposed (in their respective pockets).This plane thus acts as a reference plane, or zero height. In someembodiments the haptics have a height of about 2.88 mm. Some haptics mayhave a designed height slightly greater than their actual height in theconfiguration in the base. In some embodiments the distance between thebottom of the spokes and the base surface on which the lens rests isbetween about 2.750 mm and about 2.850 mm. In some embodiments thisdistance is just less than the haptic height. In some embodiments thespoke height is about 0.200 mm. This distance isolates the interactionbetween the haptic and the carrier to the spokes alone and preventscompression coming from a larger surface.

The compression to the haptics is limited to locations on the hapticthat result both in low deformation of the haptic and high holdingstability. FIG. 22 illustrates the relative position of spokes 355 andhaptics 341 and 342. IOL 340 includes an optic portion coupled to twohaptics. Each of the haptics includes a buttress portion secured to theoptic, as is described in the applications incorporated by reference.Two of the spokes each engage distal portions of the haptics. The othertwo spokes engage buttress portions of the haptics. Two of the spokesare disposed along the same imaginary line, while the other two spokesare disposed along the same imaginary line. The spokes are arranged sothat they engage the same regions of each of the two haptics. The lightcompression stabilizes the power and quality of the lens throughradiation or other sterilization processes as well as temperaturechanges or vibration effects of shipping. The light compression alsoholds the lens in position through the initiation of the splaying andloading sequences described herein.

The carrier is also adapted for lens compression verification. In thisembodiment lid 350 includes probe or sight holes 354 (three are shown)that allow for the measurement of the compression level after the lensis in place within the base and the lid has been assembled onto thebase. In some embodiments this can be performed by measuring the spoketo lens base gap through the lid and sight hole with a non-contact lasermeasurement system.

The carrier can also be adapted to enable verifying the intraocular lensquality or power during or after storage. This may be desirable ingeneral, or in particular because some intraocular lenses have thepotential to take on a very small permanent set through sterilization ordue to aging, and thus there may be a need to verify quality and powerchange of the intraocular lens in the stored configuration.

One method of assessing the circularity of a reflected concentric ringpattern may be used to look at lens quality before or after compressionof the lens. If this is to be done after the compression of the lens(e.g., after storage), the lid can be adapted with a window that wouldallow for this. In fact, the lid can include a plurality of windows(and/or the base could include one or more windows) and may be needed toallow for optical verification of the power and quality of the lensafter being compressed.

FIGS. 23-31D illustrate examples of the lid and/or the base includingone or more visualization windows formed therein. In embodiments inwhich at least one of the base and lid include one or more windows, oneor more plugs should generally be included to complete the viscoelasticpath for preparing to load the intraocular lens as well as for sealingthe lens path for loading. Plugs can be shipped attached to the finishedassembly, but in some embodiments the plugs are installed in theoperating room just prior to loading to reduce the risk of disturbingthe known compression.

FIGS. 23A and 23B show top and bottom views, respectively, of exemplarycarrier 400 that includes base 410 with a window and corresponding baseplug 454, and lid 450 with a window and corresponding lid plug 452.Other components in the embodiments in FIGS. 16-22 are intended to beincluded in these embodiments even if not specifically mentioned herein.The plugs can be removed, respectively, to visualize the top or bottomof the IOL that is disposed inside the carrier. The windows arepositioned within the lid and base in order to visualize the opticportion of the intraocular lens, as is shown in FIG. 24 with lid plug452 removed. Lid 450 is shown as transparent to enable visualization ofleading haptic 441, trailing haptic 442, and other components of thecarrier. Optic portion 443 is viewed through window 456.

FIGS. 25A and 25B are perspective exploded top and bottom views,respectively, or lid 450, window 456 formed therein, and plug 452. Plug452 includes a slot portion that is aligned with the slot in the bottomsurface of the lid, as is described herein. FIGS. 26A and 26B showassembly views of FIGS. 32A and 32B.

FIGS. 27A-30 illustrate an exemplary embodiment of base 410 thatincludes a window on the bottom to allow visualization of theintraocular lens optic. Base 410 and base plug 480 are configured tomate and to be secured together so that window 412 can be plugged withplug 480. FIG. 27A shows a top perspective exploded view of base 410 andplug 480. FIG. 27B shows a close-up bottom perspective exploded view ofbase 410, including window 412, and plug 480. FIG. 28 is a perspectiveview of plug 480 showing fluid communication between fluid port 481 ofplug 480, internal fluid channel 483, and outlet fluid port 482. Theshape of the plug is shaped to mate with the base. Plug 480 is, in thisembodiment, secured to base 410 with seven deformable locks 414, whichare part of base 410. Only three of the locks 414 are labeled in FIG.27B. FIG. 30 show a bottom view with plug in place to plug up thewindow, showing the locks 414 that hold plug in place. The plug can beremoved by pulling on the fluid port 481 outer surface, in a downwarddirection. FIG. 29 shows the plug 480 and base 410 assembled, withoutlet fluid port 482 in fluid communication with the inside of base410. Plug 480 includes an element 484 (see FIG. 28 ) adapted to fitwithin window 412. In this embodiment they are circular, but could be adifferent shape. In this embodiment the base plug includes a fluid port,which will be described below in the context of the methods of use.

FIGS. 31A-31B show top and bottom assembled views of the lids, bases,and plugs in the embodiments in FIGS. 25A-30 . FIG. 31A is a top view,while FIG. 31C is a top close-up view of plug 452. FIG. 31B is a bottomview, while FIG. 31D is a close-up of that view.

The disclosure also includes exemplary methods of loading an exemplaryintraocular lens from any of the carriers herein into an exemplarycartridge, wherein the intraocular lens can be subsequently be deliveredfrom the cartridge into an eye. The methods will be described generallywithout reference to specific parts of the devices herein, althoughexamples will be given in the context of certain embodiments. Not allsteps need necessarily be performed, and the order may vary. Before theIOL is loaded into the cartridge, however, the IOL may be stored in thecarrier for any length of time. To prepare the IOL for storage, theintraocular lens is positioned in the IOL receiving region in thecarrier base, such as IOL receiving region 314 shown in FIG. 17 . Thelid is then placed on top of the base, while positioning the posts inthe post guides.

When the IOL is ready to be loaded in the cartridge (or other deliverydevice or delivery lumen), a cartridge can be secured to the carrierbase, such as is shown in FIGS. 18 and 19 . In FIGS. 18 and 19 carrier300 includes mounting tabs 372 and 374 that are asymmetric. Tab 372 islonger than tab 374, both of which are adapted to engage with asymmetricapertures 382 and 384 in cartridge 360. This can help position thecartridge right side up, so that the bevel at the distal end of thecartridge is facing down when the IOL is delivered from the cartridge.The asymmetric tabs also protect the user from mounting the cartridgeupside down, which would result in an inverted lens delivery.

After the cartridge is secured to the carrier base, a viscoelasticsubstance is then introduced through a side luer port of the carrierbase to fill the lens chamber in the carrier base, which lubricates thelens and the loading path. An exemplary side port is port 319 shown inFIG. 16 . Alternatively, tab 480 shown in FIG. 27A-30 can be the sideport. A mark 399 (see FIG. 21 ) defined on the lid or base shows thecorrect volume of viscoelastic for use. Mark 399 as shown in FIGS. 21and 22 is about a 30 degree arc.

As can be seen in FIG. 17 , side port 319 is in fluid communication withan exit fluid port on the bottom of the base in the IOL receivingregion, similar in configuration to port 482 in plug 480. The portconveys viscoelastic from a syringe or other viscoelastic delivery aidto the area around the IOL prior to the splaying and loading steps. Thelocation of the fluid exit port that is nearest the lens should bepositioned so that flow of the viscoelastic does not dislocate the IOLfrom its position prior to splaying and loading. In the embodiment inFIG. 17 , the location of the exit port is at the center of the opticportion receiving area, however is could be moved to other locations,such as closer to the leading haptic. The size of this port can controlthe user's ability to create flow. In some embodiments the orificediameter is about 0.010 in.

It is of note that the IOL is maintained in a position in which theleading haptic buttress shoulder, where the haptic is coupled to theoptic portion, is in close proximity to the buttress traction pad on thebase, such as buttress traction pad 318 shown in FIG. 16 . This isgenerally important for stability of the IOL's position as the leadinghaptic is splayed.

The method of loading also includes splaying the leading haptic. FIGS.32A-32C illustrate a sequence of loading the IOL from FIG. 16 (only aportion of the carrier is shown for clarity). In FIG. 32A the IOL ispositioned in the carrier base just as is shown in FIG. 16 . The freeend of the leading haptic is proximally facing and is accessible in theproximal direction for direct contact and actuation. To initiate theleading haptic splaying, splaying member 320 is advanced distally withinthe carrier. Extension 324 on splaying member 320 is configured to fitbetween leading haptic 341 and optic portion 343 as splaying member 320continues to be advanced distally. As splaying member 320 continues tobe advanced distally, splaying member 320 engages leading haptic 341,bending leading haptic 341 away from optic portion 343 and towards thecartridge. Region 345 of leading haptic 341 is a thinner region ofhaptic 341 and is described in more detailed in the applicationsincorporated by reference herein. Region 345 acts similar to a livinghinge, so that as splaying member 320 is advanced, haptic 341 willreliably bend at the hinge (see FIG. 32B). Splay member 320 is advanceduntil the distal end 321 engages splay member stop 316, as shown in FIG.32B. In FIG. 32B leading haptic 341 has been splayed distally, and hasbeen reoriented from the at-rest orientation (relative to the optic) inFIG. 32A to an orientation that extends away from the optic, andgenerally faces distally towards the cartridge delivery lumen.

As splaying member 320 is advanced and as it engages stop 316, release323 will push lock-out 313 radially, allowing push member 330 to beadvanced distally to load the IOL.

Push member 330 is then advanced distally within the carrier base asshown in FIG. 32C. Extension 332, which in an at-rest state extendsslightly upward from body 333 (see FIG. 20 ) rides in slot 356 in lid350 (see FIG. 17 ). Extension 332 is pressed over the top of the opticportion 343 by a descending ramp in the lid slot 356, as can be seen inFIG. 17 . Positioning extension 332 over the optic portion adds axialstability to the optic for the force applied to the trailing buttress bythe second extension 334 of the push member (see FIG. 20 ). Secondextension 334 introduces a force to the trailing buttress, as can beseen in FIG. 32C, while stabilizing it so it does not shift under secondextension 334 as it moves forward. Any trailing haptic material thatslides under the second extension 334 into space 337 (see FIG. 20 )during movement has ample clearance under second extension 334 and isprotected from being pinched. Positioning the first extension 332 overthe optic helps create the fold of the optic along the line of the firstextension 332 as the IOL enters the tapering distal section of thecarrier, as shown in FIG. 32C. Pusher member 330 continues to beadvanced until the trailing haptic is splayed as well extendingproximally away from the optic portion. Pusher member 330 continues tobe advanced until the IOL enters into the cartridge, in the same generalconfiguration as shown in FIG. 13 . Method steps described above withrespect to FIGS. 1-13 can also occur during the splaying and loadingmethods described with respect to FIGS. 32A-32C.

What is claimed is:
 1. A device for loading an intraocular lens,comprising: a base member, comprising: an intraocular lens receivingregion configured to house an intraocular lens, and a cartridgereceiving region; a side port for receiving a fluid, wherein the sideport is in fluid communication with the intraocular lens receivingregion; and a cartridge configured to be coupled to the cartridgereceiving region of the base member, wherein the cartridge is configuredto receive the intraocular lens from the intraocular lens receivingregion after the intraocular lens receiving region is lubricated by thefluid introduced through the side port.
 2. The device of claim 1,further comprising a lid configured to cover at least part of theintraocular lens receiving region when coupled to the base member. 3.The device of claim 2, wherein the lid is configured to compress atleast part of the intraocular lens when coupled to the base member. 4.The device of claim 2, wherein at least part of the lid is transparent.5. The device of claim 2, wherein the lid comprises a window, whereinthe window allows a power and lens quality of the intraocular lens to beassessed when the intraocular lens is housed within the intraocular lensreceiving region.
 6. The device of claim 5, wherein the window isconfigured to be covered by a lid plug.
 7. The device of claim 1,wherein the side port is in fluid communication with an exit port influid communication with the intraocular lens receiving region, whereinthe exit port is positioned such that the fluid entering through theside port and exiting through the exit port is conveyed to an areaaround the intraocular lens.
 8. The device of claim 1, wherein the basemember comprises a window, wherein the window allows a power and lensquality of the intraocular lens to be assessed when housed within theintraocular lens receiving region.
 9. The device of claim 8, furthercomprising a base plug configured to cover the window, wherein the baseplug comprises the side port.
 10. The device of claim 1, wherein thefluid is a viscoelastic fluid.
 11. A method of preparing an intraocularlens for delivery into an eye, comprising: introducing a fluid through aside port into an intraocular lens receiving region of a base member,wherein the intraocular lens receiving region is configured to house anintraocular lens; and loading the intraocular lens into a cartridgecoupled to the base member using a loading member.
 12. The method ofclaim 11, further comprising coupling a lid to the base member to coverat least part of the intraocular lens receiving region.
 13. The methodof claim 12, wherein the lid is configured to compress at least part ofthe intraocular lens when coupled to the base member.
 14. The method ofclaim 12, wherein at least part of the lid is transparent.
 15. Themethod of claim 12, wherein the lid comprises a window, wherein thewindow allows a power and lens quality of the intraocular lens to beassessed when housed within the intraocular lens receiving region. 16.The method of claim 15, further comprising covering the window with alid plug.
 17. The method of claim 11, wherein the side port is in fluidcommunication with an exit port in fluid communication with theintraocular lens receiving region, wherein the exit port is positionedsuch that the fluid entering through the side port and exiting throughthe exit port is conveyed to an area around the intraocular lens. 18.The method of claim 11, wherein the base member comprises a window,wherein the window allows a power and lens quality of the intraocularlens to be assessed when the intraocular lens is housed within theintraocular lens receiving region.
 19. The method of claim 18, furthercomprising covering the window with a base plug, wherein the base plugcomprises the side port.
 20. The method of claim 11, wherein the fluidis a viscoelastic fluid.